32 results
Primary objective- To explore the pharmacodynamic effects of topically applied IMQ (in combination with or without TS) - To identify dose-response relationship of topically applied IMQ Secondary objective- To assess safety and tolerability of…
To assess the efficacy, evaluate the safety and immunological effect of topical 5% imiquimod cream for vulvar Paget*s disease and the quality of life during treatment.
Primary objective: To evaluate if adequate exposure to ribavirin can be achieved after a dose adjustment based on the AUC0-4h from a first dose of ribavirin.Secondary:• To evaluate how many patients need a dose adjustment to achieve adequate…
Primary objective:To compare the immunological response to vaccination with HPV16 E6 and E7 synthetic long peptides with concomitant application of imiquimod at the vaccination site with vaccination without the concomitant application of imiquimod.…
Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…
The primary objectives of this study are as follows:• To determine the efficacy of treatment with GS-7977+ribavirin (RBV) compared as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (…
The primary objective of this study is to evaluate the safety and antiviral efficacy, defined as the percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12; HCV RNA < LLOQ 12 weeks after the last dose of study…
The primary objectives of this study are to evaluate the safety of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 with and without RBV, and to show the non-inferiority in SVR12 rates (the percentage of subjects achieving a 12-week…
(1) To generate new clinical efficacy and safety data to support the registration of Insuman Implantable 400 IU/ml,(2) To ensure the continuation of the treatment of the patients already implanted and avoid pump explantation, up to the approval of…
Is the area under the curve (AUC) of the dose ribavirin once daily equal to the AUC of a half dose twice daily?
The primary objective is to demonstrate the superior efficacy of telaprevir in combination withPeg-IFN alfa-2a and RBV compared to standard treatment in subjects with chronic HCVgenotype 1 infection who failed prior treatment with Peg-IFN plus RBV.…
The primary objective is: To evaluate the efficacy, safety and tolerability of NIM811 administered in combination with SOC in an interferon-relapser population of patients infected with chronic hepatitis C genotype-1.Secundary objectives are: * To…
To investigate if high-dose ribavirin in combination with peginterferon alfa-2a can improve outcome in treatment naïve hepatitis C patients with genotype 1 or 4 and a high viral load (>400.000 IU/ml).
Primary objective: * Examine the safety and tolerability, both local and general, of ProCervix Solution (escalating doses) and ProCervix Powder in women infected by HPV 16 and/or 18 with normal cytology from Week 0 to Week 10. Secondary objectives…
Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…
The objective of this trial is to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with Peg IFN alfa2a (…
The primary objectives of this study are:•To explore the antiviral efficacy of combination therapy with SOF/LDV FDC + RBV for12 or 24 weeks in subjects with advanced liver disease (either pre-liver transplant or notcurrently wait-listed) and post-…
Primary Objectives:The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.Secondary…
Primary Objective(s) & HypothesisObjective: To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy…
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI207127 in combination with 120 mg QD Faldaprevir and RBV for 16 and 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including a…